Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.
Regulatory Updates
MHRA opens applications to join the AI Airlock regulatory sandbox
On 23rd September, the Medicines and Healthcare products Regulatory Agency (MHRA) launched the Artificial Intelligence (AI) Airlock regulatory sandbox, inviting AI medical device developers to participate. This initiative helps companies navigate regulatory challenges and is part of the MHRA’s continuing work to develop a robust MedTech regulatory framework that prioritises patient safety, gives patients access to the medical devices they need, supports the NHS transformation and ensures the UK becomes an even more attractive market for medical technology innovators.
MHRA guidance updates
- Project Orbis. On 24th September, Truqab was added to the Overview of Orbis Project approvals. The project provides a framework for concurrent submission and review of oncology products among international partners and aims to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies. Click to view source
- Apply to release a vaccine or a blood product to market. On 25th September, the MHRA updated guidance for those who wish to apply to release a vaccine or a blood product to market in the UK. This includes an updated submitting a marketing information form (MIF) and updated contact information. Click to view source
- Clinical investigations guidance. On 26th September, the section on ‘Amendments’ was updated to reflect changes to the process on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Click to view source
ICH E11A: Pediatric Extrapolation
On 25th September, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) added the ICH E11A Introductory Training Presentation to its website.
FDA guidance updates
- Chemical Analysis for Biocompatibility Assessment of Medical Devices. On 19th September, the US Food and Drug Administration (FDA) published draft guidance with recommendations on analytical chemistry testing to assess the biocompatibility of medical devices. Click to view source
- The Accreditation Scheme for Conformity Assessment (ASCA) Program. On 23rd September, guidance was published to provide technical recommendations to sponsors for the submission of animal and human study data and related information in a standardised electronic format in certain investigational new drug applications (INDs), new drug applications (NDAs); abbreviated new drug applications (ANDAs); and certain biologics license applications (BLAs). Click to view source
Industry Updates
Serán announces $200M Bain-led investment to build new commercial facility
On 17th September, Serán BioScience, a leading contract development and manufacturing organisation (CDMO) providing services to pharmaceutical and biotechnology companies, announced a strategic growth transaction exceeding $200 million, led by Bain Capital Life Sciences, to expand its commercial capabilities in Oregon. The funding will facilitate the construction of a state-of-the-art manufacturing facility for drug delivery technologies, including spray drying and particle engineering. The new facility aims to support the development of complex medicines, with completion expected in 2026.
£2.7 million trial aims to improve gallstone treatment in Leeds
On 18th September, it was announced that a clinical trial, led by Leeds Teaching Hospitals NHS Trust and the Clinical Trials Research Unit at the University of Leeds, seeks to resolve the clinical uncertainty surrounding whether patients benefit from gallbladder removal following successful Endoscopic Retrograde Cholangiopancreatography (ERCP). The research, funded by the National Institute for Health and Care Research (NIHR), will be conducted over three years, and involve 1,318 patients across more than 30 hospitals in the UK. Participants will be randomly assigned to one of two groups: one will undergo gallbladder removal surgery, while the other will be closely monitored without surgery.
EMA recommends extending indication of mpox vaccine to adolescents
On 19th September, the European Medicines Agency (EMA) announced its recommendation to extend the use of the Imvanex mpox vaccine to adolescents from 12 to 17 years of age, based on data showing a similar immune response and safety profile to that in adults. The agency’s assessment has important implications for the global response to the mpox outbreak in the Democratic Republic of the Congo (DRC) and other countries, which was declared a public health emergency of international concern (PHEIC) by the World Health Organisation (WHO) in August 2024.
FDA approves isatuximab-irfc combination for newly diagnosed multiple myeloma
On 20th September, the FDA approved isatuximab-irfc (Sarclisa, Sanofi-Aventis U.S. LLC) with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). The approval was based on clinical trial results showing a significant improvement in progression-free survival.
Highlights from the latest CHMP meeting
On 20th September, the EMA issued meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), held on the 16th-19th September 2024. Highlights include eight new medicines recommended for approval and the latest CHMP statistics.
CF AMR Syndicate announces first cohort of awardees of £3m Collaborative Drug Discovery Programme
On 23rd September, the Cystic Fibrosis Antimicrobial Resistance (CF AMR) Syndicate announced the first cohort of awardees of its Collaborative Discovery Programme (CDP) funding. The £3 million programme, funded by LifeArc, will support six early-stage novel antimicrobial projects over two years to accelerate new treatments for lung infections in people with Cystic Fibrosis (CF). These projects align with the CF AMR Syndicate’s Therapeutic Target Product Profiles for CF lung infections, which define characteristics that new antimicrobials would need to meet to fulfil the needs and priorities of people with CF.
AlgoTx completes pivotal phase 2 trial for ground-breaking CIPN treatment
On 24th September, AlgoTherapeutix (AlgoTx), a clinical stage biotechnology company, announced the completion of the Last Patient Last Visit (LPLV) in its Phase II trial of ATX01, aimed at treating chemotherapy-induced peripheral neuropathy (CIPN). Under Professor Guido Cavaletti of the University of Milano-Bicocca, the ‘ACT (ATX01 in ChemoTherapy-induced peripheral neuropathy)’ trial spanned over 40 sites across the US and Europe and was designed as a double-blind, placebo-controlled study to rigorously assess the efficacy and safety of the treatment in patients with CIPN.
Issue Number: WN00181
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